Common use of Validation/Qualification Clause in Contracts

Validation/Qualification. 10.1 Maintain a written master validation/qualification plan for the facilities, equipment/instruments, manufacturing process, cleaning procedures, analytical procedures, in process control tests and computerized systems approved by the quality unit. --- --- × 10.2 Prepare and maintain validation/qualification documentation approved by the quality unit, including protocols, reports and associated documentation. Provide such documents during audits. --- --- × 10.3 Sections 10.3 through 10.10 are only applicable to new or replaced equipment. Validate/qualify as necessary all critical systems, utilities and equipment/instruments used for the manufacture and control of Product (Installation Qualification (IQ), Operational Qualification (OQ), and/or Performance Qualification (PQ)). --- --- × 10.4 Computer systems and associated software used in Good Manufacturing Practices related activities associated with the Product should be validated/qualified. Procedures must be in place to assure the integrity, archiving, retrieval and destruction of the electronic data that comply with applicable regulations. --- --- × 10.5 Validate/qualify methods and procedures for cleaning of equipment with acceptance criteria for residues defined and justified. --- --- × 10.6 Develop and execute a plan for process and method validation/qualification. --- --- × 10.7 Where method validation is performed by Manufacturer: • Manufacturer shall write method validation protocol, • Manufacturer shall review and approve method validation protocol • Manufacturer shall execute method validation protocol, • Manufacturer shall write method validation report, and • Manufacturer shall review and approve method validation report. --- --- × --- --- × --- --- × --- --- × --- --- × 10.8 For process validation: • Write process validation protocol, • Review and approve process validation protocol. • Execute process validation protocol, • Write process validation report, and • Review and approve process validation report. --- --- × --- --- × --- --- × --- --- × --- --- × 10.9 Validate/qualify all manufacturing processes, Product formulation, mixing operations and hold times for the formulation process according to Nordmark SOP. --- --- × 10.10 Evaluate protocol deviations encountered during validation/qualification to determine impact on validation/qualification studies, including need to conduct repeat studies. --- --- × 10.11 Evaluate validated/qualified systems and processes periodically to verify they are still operating in a valid manner. --- --- ×

Validation/Qualification. 10.1 Maintain 11.01 Define all process parameters, critical process control points and quality attributes and Specifications. [***] [***] 11.02 Have a written master validation/qualification plan for the facilities, equipment/instruments, manufacturing process, cleaning procedures, analytical procedures, in process control tests and computerized systems approved by the quality unitQuality Unit (as appropriate). --- --- ×[***] [***] 10.2 11.03 Prepare and maintain validation/qualification documentation approved by the quality unitQuality Unit, including protocols, reports and associated documentation. Provide such documents during auditsto XERIS upon request. --- --- ×[***] [***] Document No: QAA-XERIS Revision: 03 Revision Date: 11/16/20 Replaces: 02 Page: 29 of 40 10.3 Sections 10.3 through 10.10 are only applicable to new or replaced equipment. 11.04 Validate/qualify as necessary all critical systems, utilities and equipment/instruments used for the manufacture and control of Product product (through Installation Qualification (IQ), Operational Qualification (OQ), and/or Performance Qualification (PQ)). --- --- ×[***] [***] 10.4 Computer 11.05 Validate/qualify computer systems and associated software used in Good Manufacturing Practices cGMP-related activities associated with the Product should be validated/qualifiedproduct. Procedures procedures must be in place to assure ensure the integrity, archiving, retrieval and destruction of the electronic data that comply with applicable regulations. --- --- ×[***] [***] 10.5 11.06 Validate/qualify methods and procedures for cleaning of equipment with acceptance criteria for residues defined and justified. --- --- ×Alternative evaluations of cleaning validation/qualification (dedicated equipment, matrix approach, worst case scenario, etc.) are to be approved by XERIS. [***] [***] 10.6 11.07 Develop and execute a plan for process and method validation/qualificationqualification including definition of roles and responsibilities between PYRAMID and XERIS for performing technology transfers, if applicable. --- --- ×[***] [***] 10.7 11.08 Where method validation is performed by ManufacturerPYRAMID: [***] [***] • Manufacturer shall write Write method validation protocol, [***] [***] • Manufacturer shall review Review and approve method validation protocol protocol, [***] [***] • Manufacturer shall execute Execute method validation protocol, [***] [***] • Manufacturer shall write Write method validation report, and [***] [***] • Manufacturer shall review Review and approve method validation report. --- --- × --- --- × --- --- × --- --- × --- --- ×[***] [***] 10.8 11.09 For process validation: [***] [***] • Write process validation protocol, [***] [***] • Review and approve process validation protocol. , [***] [***] • Execute process validation protocol, [***] [***] • Write process validation report, and [***] [***] • Review and approve process validation report. --- --- × --- --- × --- --- × --- --- × --- --- ×[***] [***] 10.9 11.10 Validate/qualify all manufacturing processes, Product product formulation, mixing operations and hold times for the formulation process according to Nordmark SOPprocess. --- --- ×[***] [***] 10.10 11.11 Qualify time limitations for each phase of production. [***] [***] 11.12 Evaluate protocol deviations encountered during validation/qualification to determine impact on validation/qualification studies, including need to conduct repeat studies. --- --- ×[***] [***] 10.11 11.13 Evaluate validated/qualified systems and processes periodically to verify they are still operating in a valid manner. --- --- ×[***] [***] 11.14 Report all media simulation failures for Product related aseptic manufacturing processes. [***] [***] 11.15 Permit a representative of XERIS to be present during process demonstration and validation. [***] [***] 11.16 Validate / qualify bioburden and sterility assays. [***] [***]

Validation/Qualification. 10.1 Maintain a 10.01 Have an appropriate written master validation/qualification plan for the facilities, equipment/instruments, manufacturing packaging process, cleaning procedures, analytical procedures, in process control tests and computerized systems approved by the quality unit. --- --- ×X 10.2 10.02 Prepare and maintain validation/qualification documentation approved by the quality unit, including protocols, reports and associated documentation. Provide such documents during auditsto Customer upon request. --- --- ×X 10.3 Sections 10.3 through 10.10 are only applicable to new or replaced equipment. 10.03 Validate/qualify as necessary all critical systems, utilities and equipment/instruments used for the manufacture packaging and control of Product (Installation Qualification (IQ), Operational Qualification (OQ), and/or Performance Qualification (PQ), Package Validation (PV)). --- --- ×X 10.4 Computer 10.04 Validate/qualify computer systems and associated software used in Good Manufacturing Practices related activities associated with the Product should be validated/qualifiedProduct. Procedures must be in place to assure the integrity, archivingarchival, X retrieval and destruction of the electronic data that comply with applicable regulations. --- --- ×. 10.5 10.05 Validate/qualify methods and procedures for cleaning of equipment with acceptance criteria for residues defined and justified. --- --- ×X 10.6 10.06 Develop and execute a plan for process and method validation/qualificationqualification including definition of roles and responsibilities between PCI and Customer for performing technology transfers. --- --- ×X X 10.7 10.07 Where method validation is performed by ManufacturerPCI: • Manufacturer · PCI shall write method validation protocol, • Manufacturer X · PCI and Customer shall review and approve method validation protocol • Manufacturer protocol, X X · PCI shall execute method validation protocol, • Manufacturer X · PCI shall write method validation report, and • Manufacturer X · PCI and Customer shall review and approve method validation report. --- --- × --- --- × --- --- × --- --- × --- --- ×X X 10.8 10.08 For process validation: • Write · PCI shall write process validation protocol, • Review X · PCI and Customer shall review and approve process validation protocol. • Execute , X X · PCI shall execute process validation protocol, • Write X · PCI shall write process validation report, and • Review X · PCI and Customer shall review and approve process validation reportreports. --- --- × --- --- × --- --- × --- --- × --- --- ×X X 10.9 10.09 Validate/qualify all manufacturing processes, Product formulation, mixing operations and hold times for the formulation process according to Nordmark SOPprimary packaging processes unless otherwise agreed by Customer. --- --- ×X 10.10 Evaluate protocol deviations encountered during validation/qualification to determine impact on validation/qualification studies, including need to conduct repeat studies. --- --- ×X 10.11 Evaluate validated/qualified systems and processes periodically to verify they are still operating in a valid manner. --- --- ×X

Validation/Qualification. 10.1 Maintain a written master validation/qualification plan for the facilities, equipment/instruments, manufacturing process, cleaning procedures, analytical procedures, in process control tests and computerized systems approved by the quality unit. --- --- × 10.2 Prepare and maintain validation/qualification documentation approved by the quality unit, including protocols, reports and associated documentation. Provide such documents during audits. --- --- × 10.3 Sections 10.3 through 10.10 are only applicable to new or replaced equipment. Validate/qualify as necessary all critical systems, utilities and equipment/instruments used for the manufacture and control of Product (Installation Qualification (IQ), Operational Qualification (OQ), and/or Performance Qualification (PQ)). --- --- × 10.4 Computer systems and associated software used in Good Manufacturing Practices related activities associated with the Product should be validated/qualified. Procedures must be in place to assure the integrity, archiving, retrieval and destruction of the electronic data that comply with applicable regulations. --- --- × 10.5 Validate/qualify methods and procedures for cleaning of equipment with acceptance criteria for residues defined and justified. --- --- × 10.6 Develop and execute a plan for process and method validation/qualification. --- --- × 10.7 Where method validation is performed by Manufacturer: • Manufacturer shall write method validation protocol, • --- --- × Manufacturer shall review and approve method validation protocol • --- --- × Manufacturer shall execute method validation protocol, • --- --- × Manufacturer shall write method validation report, and • --- --- × Manufacturer shall review and approve method validation report. --- --- × --- --- × --- --- × --- --- × --- --- × 10.8 For process validation: • Write process validation protocol, • --- --- × Review and approve process validation protocol. • --- --- × Execute process validation protocol, • --- --- × Write process validation report, and • --- --- × Review and approve process validation report. --- --- × --- --- × --- --- × --- --- × --- --- × 10.9 Validate/qualify all manufacturing processes, Product formulation, mixing operations and hold times for the formulation process according to Nordmark SOP. --- --- × 10.10 Evaluate protocol deviations encountered during validation/qualification to determine impact on validation/qualification studies, including need to conduct repeat studies. --- --- × 10.11 Evaluate validated/qualified systems and processes periodically to verify they are still operating in a valid manner. --- --- ×